Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction (VIP-HF2)

Heart failure (HF) with a left ventricular ejection fraction (LVEF) >0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF >0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile

Study Overview

• Status: Recruiting
• Conditions: Heart Failure, Diastolic
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: 24 hour Holter monitoring; Diagnostic test: Cardiac Magnetic Resonance Imaging; Diagnostic test: 99mTc-HDP scan; Diagnostic test: ECG

Detailed Description

Objective: To assess the risk profile associated with the combined endpoint of all-cause mortality and HF hospitalizations in HF patients with LVEF >0.40.

Study design: Single-center, prospective, study.

Study population: We aim 200 patients with symptomatic heart failure (NYHA class II-III), and a recent HF hospitalization, emergency room visit or symptom relief with diuretics who have a left ventricular ejection fraction >0.40, echocardiographic evidence of left atrial enlargement or left ventricular hypertrophy, and elevated concentrations of BNP or NT-proBNP.

Study procedures: All patients will undergo echocardiography, cardiac magnetic resonance (CMR) imaging, Holter recording and blood sampling at inclusion. The 99mTc-HDP scan is optional.There is no control group.

Total follow up: Up to five years.

Main study endpoint: incidence of the combined endpoint of all-cause mortality and HF hospitalizations.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Michiel Rienstra, MD PhD; Phone Number: 0031503612878; Email: m.rienstra@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Contact: Michiel Rienstra, MD PhD; Phone Number: 0031503612878; Email: m.rienstra@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To avoid the inclusion of patients with dyspnea due to other causes, we use specific (see below) echocardiographic and biomarker criteria. From several studies is known that in patients with HF with LVEF >0.40 or AF, NT-proBNP or BNP is strongly associated with mortality an HF hospitalizations. The use of biomarker criteria will therefore help to select patients with an increased mortality risk. Therefore, by selecting HF patients with LVEF >0.40 with a previous HF hospitalization we aim to include patients at increased risk for mortality and HF hospitalizations.

Description

Inclusion Criteria:

Clinical criteria:

1. Age >18 years
2. Written informed consent
3. HF with moderate to severe symptoms NYHA II or III
4. Hospitalization or emergency room visit for HF or symptom relief with diuretics
5. Sinus rhythm or AF

Echocardiographic criteria:

1. LVEF >0.40
2. Left atrial size (volume ≥29 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s).

Biomarker criteria:

1. BNP >31ng/L or NT-pro-BNP>125ng/L if sinus rhythm
2. BNP >75ng/L or NT-pro-BNP>300ng/L if atrial fibrillation

Exclusion Criteria:

1. Patients unwilling or unable to sign informed consent
2. Patients with a pacemaker or ICD
3. Indication for ICD therapy according to the ESC guidelines
4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction < 3 months
6. Complex congenital heart disease
7. Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined endpoint of all-cause mortality and hospitalization for heart failure	The incidence of the combined endpoint of all-cause mortality and first heart failure hospitalization	5 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Michiel Rienstra, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: heart failure with preserved ejection fraction; cardiac MRI; HFpEF; 99mTc-HDP scan
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Other Study ID Numbers: VIP-HF 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No